Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) [ Time Frame: From Day 1 Visit to Day 10 Visit, and during treatment up to 3 days after interrupting or stopping study drug ] [ Designated as safety issue: Yes ]

Recurrence of VTE [ Time Frame: 90 days from time of randomization ] [ Designated as safety issue: No ]

Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance imaging (MRI) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.

Detailed Description

The classical management of patients with venous thromboembolism (VTE) consists of an initial treatment of at least five days of a (LMW) heparin followed by long-term treatment with a vitamin K antagonist (VKA), such as warfarin. The eTRIS study will address the clinically important question of whether edoxaban monotherapy, without concomitant (LMW) heparin at the time of treatment initiation is comparable to or better than standard treatment with (LMW) heparin/warfarin therapy in subjects with acute symptomatic DVT as assessed by the relative change from baseline in thrombus volume (measured by MRI) at Day 14-21.

Concomitant pulmonary embolism known to the investigator at the time of randomization

Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT

Indication for warfarin other than DVT

More than 48 hours pre-treatment with therapeutic dosages of anti-coagulant treatment (LMWH, UFH, fondaparinux, VKA, factor Xa inhibitor or other anti coagulant per local labeling) prior to randomization to treat the current episode

Treatment with any investigational drug within 30 days prior to randomization

Calculated CrCL < 30 mL/min

Significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or ALT > or = 2 times the upper limit of normal (ULN), or total bilirubin (TBL) > or = to 1.5 times the ULN (however subjects whose elevated TBL is due to known Gilbert's syndrome may be included in the study)

Subjects with active cancer for whom long term treatment with (LMW) heparin is anticipated

Life expectancy < 3 months

Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin

Women of childbearing potential without proper contraceptive measures (i.e., a method of contraception with a failure rate < 1 % during the course of the study including the observational period) and women who are pregnant or breast feeding

Any contraindication listed in the local labeling of LMWH, UFH, or warfarin

Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX- 2) inhibitors for > or = 4 days/week anticipated to continue during the study.

Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any two antiplatelet agents including aspirin plus any other oral or intravenous [IV] antiplatelet drug) anticipated to continue during the study

Treatment with P-gp inhibitors is not permitted at the time of randomization; subsequent use is permitted, with a dose reduction in the edoxaban monotherapy treatment arm.

Known history of positive Hepatitis B antigen or Hepatitis C antibody

Subjects with any condition that, as judged by the investigator, would put the subject at increased risk of harm if he/she participated in the study; including, but not limited to, subjects at increased risk of harm if given a gadolinium-based contrast agent such as gadofosveset trisodium (Ablavar®)

Subjects for whom MRI would be contraindicated (e.g., subjects with metal implants) or for whom the use of a gadolinium-based contrast agent such as gadofosveset trisodium (Ablavar®) would be contraindicated

Subject has previously entered this study or another edoxaban study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects